About Our Solutions

Cutting Edge Modeling and Simulation Solutions for Drug Development

Drug development has become more complex and multi-layered. New combination therapies require more precise and individualized analyses, new approaches such as “basket studies” evaluate potential disease targets through a new lens, safety issues are more challenging, and comparative effectiveness plays an increasingly important role in “go/no go” decisions. As the largest and most diverse modeling and simulation organization, Certara has developed an array of solutions to address these key issues.

Programmatic consulting delivers unquestionable value to sponsors:

Drug program and pharmacometric regulatory strategy

What are the regulatory agency expectations?

Do we have to run a C-QT study?

Have we conducted the right in vitro studies to allow us to reduce or improve clinical studies?

Simcyp physiologically-based pharmacokinetic (PBPK) strategy:

Are we best leveraging our in vitro data?

What drug-drug interaction (DDI) studies may be required by the regulatory agency and/or can we simulate the result and waive the study?